HALLS HONEY LEMON- menthol lozenge 
Mondelēz Global LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active Ingredient

<(in each drop) Menthol 9.1 mg>

Purposes

<Cough Suppressant, Oral Anesthetic>

Uses

<temporarily relieves

  • cough due to a cold
  • occasional minor irritation or sore throat>

Warnings

<Sore throat warning: if sore throat is severs, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.  These may be serious.>

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.  These could be signs of a serious condition.
  • sore mouth does not improve in 7 days
  • irritation, pain, or redness persists or worsens

Keep out of reach of children


Directions

  • adults and children 5 years and over:  dissolve 1 drop slowly in the mouth.  Repeat every 2 hours as needed
  • children under 5 years:  ask a doctor 

Other information

  • 15 calories per drop
  • contains: Soy

Inactive ingredients

<beta carotene, eucalyptus oil, flavors, glucose syrup, honey, soy lecithin, sucralose, sucrose, water>

Questions

Call 1-800-524-2854, Monday to Friday, 9 AM-6PM Eastern Time or visit our website at www.gethalls.com 

Package Principal Display Panel

OTC PDPNDC 12546-310-09 Halls Honey Lemon 9 drops package

HALLS  HONEY LEMON
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-310
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol9.1 mg
Inactive Ingredients
Ingredient NameStrength
.BETA.-CAROTENE (UNII: 01YAE03M7J)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
HONEY (UNII: Y9H1V576FH)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Coloryellow (yellow) Scoreno score
ShapeSQUARESize20mm
FlavorHONEY (hONEY LEMON) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-310-0909 in 1 PACKAGE; Type 0: Not a Combination Product10/01/201307/05/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/201307/05/2018
Labeler - Mondelēz Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Mondelēz Canada Inc246791201manufacture(12546-310)

Revised: 10/2017
 
Mondelēz Global LLC